510(k) K043041
K043041 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX)". The FDA issued a decision of Substantially Equivalent on December 9, 2004. The device falls under product code HCH (Clip, Aneurysm), a Class II device regulated under 21 CFR 882.5200. Aesculap, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 2004
- Date Received
- November 4, 2004
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clip, Aneurysm
- Device Class
- Class II
- Regulation Number
- 882.5200
- Review Panel
- NE
- Submission Type